BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PACE Applicator for dermaPACE

    Reg #: 1062240 · FEI: 3006261799 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    SANUWAVE, INC.
    Registration Number
    1062240
    FEI Number
    3006261799
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    11495 Valley View Road
    City
    Eden Prairie
    State
    MN
    ZIP
    55344
    Country
    US

    Regulatory Submissions

    510(k) Number
    DEN160037

    Owner / Operator

    Firm Name
    SANUWAVE, INC.
    Operator Number
    9083571
    Address
    11495 Valley View Road
    City
    Eden Prairie
    State
    MN
    Postal Code
    55344
    Country
    US

    Products

    Device Name Product Code
    Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers PZL

    Proprietary Names

    PACE Applicator for dermaPACE dermaPACE Console

    Establishment Types

    Remanufacture Medical Device Manufacture Medical Device